| Device | Agili-C |
| Generic Name | Implant, Resorbable, For Articular Osteochondral Repair |
| Applicant | CartiHeal Ltd.17 Atir Yeda Streetkfar Saba 44643 PMA NumberP210034 Date Received09/30/2021 Decision Date03/29/2022 Advisory Committee Orthopedic Clinical TrialsNCT03299959 Expedited Review Granted? No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-03-29 |
| PMA | P210034 |
| Supplement | S |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CartiHeal Ltd. 17 Atir Yeda Street kfar Saba 44643 PMA NumberP210034 Date Received09/30/2021 Decision Date03/29/2022 Advisory Committee Orthopedic Clinical TrialsNCT03299959 Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Agili-C™. The Agili-C™ Scaffold Is Indicated For The Treatment Of An International Cartilage Repair Society (ICRS) Grade III Or Above Knee-joint Surface Lesion(s), With A Total Treatable Area Of 1-7cm2, Without Severe Osteoarthritis (Kellgren-Lawrence Grade 0-3). Approval OrderApproval Order SummarySummary Of Safety And Effectiveness LabelingLabeling Supplements: |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210034 | Original Filing |
| Device ID | PMA | Supp |
|---|---|---|
| 07290019087038 | P210034 | 000 |
| 07290019087021 | P210034 | 000 |
| 07290019087014 | P210034 | 000 |
| 07290019087007 | P210034 | 000 |
| 07290019087182 | P210034 | 000 |
| 07290019087175 | P210034 | 000 |
| 07290019087168 | P210034 | 000 |